Indications and uses
For effective treatment of most athlete's foot and ringworm Relieves itching, scaling, cracking, burning, redness, soreness, irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.
Silka Antifungal
- Manufacturer
- Genomma Lab USA
- Effective date
- 2022-03-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:48:54
Label at a glance#
ProductSilka Antifungal
Active ingredientTolnaftate
Label structure11 sections
Dosage and administration
This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes an...
Storage and handling
Store at room temperature 15° – 30°C (59° -86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Tolnaftate 1%
Purpose
Antifungal
Uses
- For effective treatment of most athlete's foot and ringworm
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.
Warnings
For external use only
OTC - DO NOT USE SECTION
- Do not use on children under 2 years of age unless directed by a doctor.
OTC - WHEN USING SECTION
When using this product avoid contact with the eyes.
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm).
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly
- Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
- Supervise children in the use of this product
- For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- To prevent athlete's foot, apply once or twice daily (morning and/or night)
- Apply to skin around the nail and cuticle.
Other information
- Store at room temperature 15° – 30°C (59° -86°F)
Inactive ingredients
Aloe Barbadensis Leaf Extract, BHT, Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Oryza Sativa (Rice) Bran Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate.
Questions or comments?
Call toll free 1-877-994-3666
Monday to Friday, 8 am to 6 pm Central time.
SPL UNCLASSIFIED SECTION
Distributed by:
Genomma Lab., Houston, TX 77027
PRINCIPAL DISPLAY PANEL - 13 ML Bottle Carton
SILKA®
MAX STRENGTH
ANTIFUNGAL
LIQUID
- KILLS
FUNGUS - STOPS ITCHING
AND BURNING - HELPS RESTORE
SKIN HEALTH
BEFORE
AFTER
DRAMATIZATION
WITH BRUSH
APPLICATOR
CLINICALLY PROVEN
AGAINST ATHLETE'S
FOOT FUNGUS
0.45 FL OZ / 13 ML
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2704862 | SILKA 1 % Topical Solution | PSN | 2 |
| 313423 | tolnaftate 1 % Topical Solution | PSN | 2 |
| 2704862 | tolnaftate 10 MG/ML Topical Solution [Silka Antifungal] | SBD | 2 |
| 313423 | tolnaftate 10 MG/ML Topical Solution | SCD | 2 |
| 2704862 | Silka Antifungal 10 MG/ML Topical Solution | SY | 2 |
| 313423 | tolnaftate 1 % Topical Solution | SY | 2 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50066-083-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-96f4-d83d-e063-dadaa90ab31f | Silka ® Antifungal Liquid |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50066-083-01 | Silka Antifungal | 13 mL in 1 BOTTLE, GLASS | LIQUID | 13 | 2 | |
| 50066-083-01 | Silka Antifungal | 1 in 1 CARTON | LIQUID | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Silka Antifungal
- Tolnaftate
- ALOE VERA LEAF
- SAFFLOWER OIL
- HYDROGENATED POLYBUTENE (1300 MW)
- LAVENDER OIL
- TEA TREE OIL
- RICE BRAN OIL
- SESAME OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50066-083 | 50066-083-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Tolnaftate | 06KB629TKV | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| SAFFLOWER OIL | 65UEH262IS | IACT |
| HYDROGENATED POLYBUTENE (1300 MW) | 7D1YQ9Y5EZ | IACT |
| LAVENDER OIL | ZBP1YXW0H8 | IACT |
| TEA TREE OIL | VIF565UC2G | IACT |
| RICE BRAN OIL | LZO6K1506A | IACT |
| SESAME OIL | QX10HYY4QV | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e90b344a-8558-4061-9fbe-2f89b219b97b | 550d2a9b-4b23-47e5-9dc6-df1fc39a0f21 | 2022-03-23 | Warnings | e90b344a-8558-4061-9fbe-2f89b219b97b 550d2a9b-4b23-47e5-9dc6-df1fc39a0f21 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.